Midweek update

Rx coverage

Midweek update

David Ermer–CDC, Congress, COVID-19 testing, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Roll Call informs us
    • House Republicans appeared to be moving closer to an agreement Wednesday on an opening bid for stopgap funding legislation that would keep the lights on at federal agencies beyond Sept. 30 and pave the way for their chamber to take up its full-year appropriations bills.
    • At least a handful of conservative holdouts still maintained their opposition as of Wednesday night, which would be enough to sink a revised bill unless GOP leaders are able to change some minds in the next few days. Speaker Kevin McCarthy, R-Calif., is expected to keep the chamber in session on Saturday if necessary.
    • Even if GOP leaders’ new effort is successful, however, it was starting to look more like a bid to reopen the government after a brief shutdown, given the deadline is 10 days away and the Senate is likely to ping-pong a much different bill back to the House.
  • The FEHBlog notes that it would not be unusual for Congress to pass a brief continuing resolution next week to allow for the passage of a longer continuing resolution, thereby side stepping the partial government shutdown.
  • Fierce Healthcare offers details on the House Ways and Means Committee’s No Surprises Act hearing, while Healthcare Dive shares details on the House Oversight and Accountability’s PBM reform hearing. Both hearings were held yesterday.
  • Speaking of the No Surprises Act, the ACA regulators released a proposed rule increasing the government’s NSA arbitration fee from $50 per party to $150 per party next year. The FEHBlog has no idea why the government doesn’t ladder the fee based on the amount in dispute. The government also increased the maximum fee independent dispute resolution entities can charge the parties.
  • MedCity News informs us
    • “FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class 
    • “FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.”
  • and
    • “FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine 
    • “ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.”

From the public health and medical research fronts,

  • STAT News reports,
    • “The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs and in part to stimulate a domestic testing industry that has struggled with cratering demand for rapid diagnostics.
    • “The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats. * * *
    • “Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.”
  • The FEHBlog thinks that the government is fighting the last pandemic. Why not incent the production of the FDA-approved (last February) at-home tests for Covid or the flu, not just Covid?
  • In any event, the Wall Street Journal points out
    • “Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. It may still be good. 
    • “The Food and Drug Administration has been extending expiration dates for some authorized at-home, over-the-counter Covid test kits, meaning some unused tests may still be viable. The agency’s updated list of expiration dates may be useful to those reaching for their stash of Covid-19 tests amid new variants and a recent bump in cases and hospitalizations.”
  • The National Institutes of Health announced,
    • “A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.”
  • Per NBC News,
    • “Is morning the best time of day to exercise? Research published Tuesday in the journal Obesity finds that early morning activity — between 7 a.m. and 9 a.m. — could help with weight loss. 
    • “My cautious suggestion from this study is that if we choose to exercise in the early morning before we eat, we can potentially lose more weight compared to exercise at other times of the day,” said lead researcher Tongyu Ma, a research assistant professor at The Hong Kong Polytechnic University.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us
    • “Ochsner Health is launching a pilot program this month that will use generative artificial intelligence to draft “simple” messages to patients.
    • “About a hundred clinicians across the New Orleans-based health system will participate in the first phase of the program, where AI will prepare responses to patient questions unrelated to diagnoses or clinical judgments. The messages will be reviewed and edited by providers before being sent to patients, according to a news release. 
    • “Ochsner is part of an early adopter group of Microsoft’s Azure OpenAI Service, which integrates with the Epic electronic health record. The health system will test the messaging feature over three phases this fall, and Ochsner will collect patient feedback to improve the system.” 
  • Per Fierce Healthcare,
    • “Making sense of mountains of data continues to be an often elusive goal for most of the healthcare system, but Cambia Health Solutions said it hopes its latest effort will allow it to better corral useable information.
    • “Cambia and Abacus Insights, a data management company that tacklesthe challenge of making healthcare networks interoperable, launched a new data aggregating system that processes information for about 3.4 million members across four Blues plans. 
    • “According to an Abacus case study (PDF), “Cambia recognized that to deliver care orchestrated around the unique needs of each individual, data must be actionable. To be actionable, case study data must be understandable, usable, timely, and have clinical utility.”

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “House Republican leaders worked to salvage a short-term spending bill that sparked angry disagreements among the party’s rank-and-file, but they remained short of the support needed to pass the measure and show the party could unite to avert a government shutdown. * * *
    • “The effort to pass a short-term deal comes as Congress is working to pass the 12 annual appropriation bills that fund the government. Leaders of both parties in the House and Senate have thrown their support behind reaching a short-term deal that would give both chambers more time to negotiate a full-year spending agreement.
    • “Both McCarthy and Senate Minority Leader Mitch McConnell (R., Ky.) have warned of the political fallout for the GOP from a shutdown.
    • “I’ve seen a few of them over the years, they never have produced a policy change, and they’ve always been a loser for Republicans politically,” said McConnell to reporters.”
  • Govexec offers federal employees a “guide to pay and benefits during a shutdown.”
  • The House Ways and Means Committee held a No Surprises Act hearing today. Here are a link to the Chairman’s opening statement and a link to the AHIP witness statements.
  • Federal News Network tells us,
    • “Enrollees in the Federal Long-Term Care Insurance Program (FLTCIP) are bracing for another big premium increase starting in 2024.
    • “The Office of Personnel Management, which runs the federal insurance program, announced plans to hike up premium rates for current enrollees. The changes will take effect on Jan. 1.
    • “Unlike the averages offered in past years, OPM declined to share an average percentage increase for FLTCIP premiums. An agency spokesperson said the percentage increases for enrollees were too variable for an average to accurately depict how much the rates are rising.
    • “But anecdotal experiences from program participants who spoke with Federal News Network and who shared their premium notification letters with the National Active and Retired Federal Employees Association (NARFE) show the increases are as large as 86%, if the enrollees choose to stick with their same coverage options. In a few other instances, enrollees received notice from OPM that their premiums will go up 77% and 49%, according to NARFE.”
  • The U.S. Preventive Services Task Force issued a revised Grade B recommendation today. “The USPSTF recommends screening for hypertensive disorders in [asymptomatic] pregnant persons with blood pressure measurements throughout pregnancy.”
  • The Wall Street Journal adds,
    • “The recommendation made Tuesday by the U.S. Preventive Services Task Force broadens 2017 guidance to screen regularly only for preeclampsia, a dangerous and increasingly common condition that can arise in pregnancy. It involves high blood pressure along with kidney or liver trouble and other problems and is believed to occur when the placenta develops abnormally because of a problem with the blood vessels that supply it.  
    • “The recommendation applies to other disorders marked by high blood pressure that, like preeclampsia, normally develop in the second half of pregnancy. They include gestational hypertension—high blood pressure without the other signs of preeclampsia—and eclampsia, which involves seizures and is life-threatening.” 
  • Per Healthcare Dive
    • “Eighty-one percent of nursing home facilities nationwide and 90% of for-profit facilities would need to hire additional registered nurses or nurse aides to meet the minimum nursing staff hours standards proposed by the CMS earlier this month, according to a KFF estimate published Monday.”

From the public health front,

  • NBC News reports,
    • “Doctors say they’re finding it increasingly difficult to distinguish Covid from allergies or the common cold, even as hospitalizations tick up.
    • “The illness’ past hallmarks, such as a dry cough or the loss of sense of taste or smell, have become less common. Instead, doctors are observing milder disease, mostly concentrated in the upper respiratory tract. 
    • “It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” said Dr. Erick Eiting, vice chair of operations for emergency medicine at Mount Sinai Downtown in New York City.”
  • The Wall Street Journal offers “A Game Plan for Timing Your Flu, Covid, and RSV Shots This Fall.”
  • The Washington Post informs us,
    • “Doing puzzles, playing memory-boosting games, taking classes, and reading are activities that we often turn to for help keeping our brains sharp. However, research is showing that what you eat, how often you exercise, and the type of exercise you do can help lower your risk of dementia to a greater extent than previously thought.
    • “Although more studies are needed, “there’s a lot of data that suggests exercise and diet are good for the brain and can prevent or help slow down” cognitive changes, says Jeffrey Burns, co-director of the University of Kansas Alzheimer’s Disease Research Center in Fairway.
    • “And living a healthy lifestyle can produce brain benefits regardless of age.”

From the healthcare business front,

  • Fierce Health identifies the most influential minority executives in healthcare for 2023. Maazal tov to those execs.
  • Beckers Payer Issues points out,
    • “Elevance Health’s pharmacy benefit manager, CarelonRx, is launching a new integrated cost savings program to automatically offer members the lowest price for generic prescription drugs at their preferred pharmacy.
    • “We will automatically compare prices to emulate a comparative shopping experience, similar to when a member would use a discount card,” Michele Paige, vice president of product at CarelonRx, told Becker’s. “But now they don’t have to because it’s integrated within their benefits.” 
    • “The new program, EnsureRx, is set to launch in February and will automatically compare prices for more than 50 generic medications against a variety of cash discount cards, with savings automatically applied. Ms. Paige shared that the list of generic medications covered will be constantly evaluated for potential additions.” 
  • and
    • “Cigna Healthcare offers employers a supplemental benefit designed to help employees diagnosed with musculoskeletal conditions. 
    • “The payer is adding musculoskeletal conditions to its Supplemental Health Critical Illness plans, according to a Sept. 18 news release. The program provides an annual payment of $3,000 to employees to help them cover out-of-pocket hospital costs or other expenses such as rent, childcare and groceries. 
    • “Cigna offers similar benefits for cancer, heart attack and stroke.” 

Monday Roundup

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports
    • “House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
    • “The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
    • “The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
  • Politico discusses where we stand with the proposed mental health parity rule changes.
    • “The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
    • “Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
    • “For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
    • “The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
    • “The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
  • The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
    • “Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order.  On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations.  The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
  • The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
    • AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
    • TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
    • STAGE: Final Rule Economically Significant: No
    • RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
    • REVIEW EXTENDED
    • COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
  • The FEHBlog will be watching the Federal Register for this one.
  • CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”

From the public health and medical research fronts,

  • Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
  • NPR reports,
    • “The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
    • “Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
    • “We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
  • Healio points out that based on a recent research study,
    • “Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
    • “Fructose from vegetables and fruits was not.”
  • The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
  • Health Day notes based on a Swedish study,
    • “Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
    • “A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
    • “Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
  • MedPage Today calls our attention to a different Swedish study,
    • “Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
  • Per NIH,
    • “Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
    • “Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”

From the U.S. healthcare business and quality fronts,

  • Beckers Payer Issues reports
    • The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
    • The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
    • Commercial plans that received a five-star rating:
      • Independent Health Association (New York)
      • Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
  • Per Healthcare Dive
    • ‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
    • ‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
    • ‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
    • That’s a big bowl of wrong.
  • Reuters reports,
    • “Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
    • “Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
  • mHealth Intelligence tells us
    • The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
    • The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
    • Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.

In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The American Hospital Association News tells us
    • “The House Energy and Commerce Committee today held a hearing on legislative proposals to prevent and respond to generic drug shortages. In comments submitted last month, AHA urged the committee to reject provisions in its draft legislation proposals that would limit patient access to 340B drugs and consider additional proposals that would protect the supply chain for essential medications.
    • “Witnesses at today’s hearing included representatives from Civica, the American Society for Health System Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance, and Association for Accessible Medicines.”
  • STAT News adds,
    • “Although shortages are not new, the number of drugs in short supply has grown steadily for about two years. Shortages also have become more difficult to predict and are affecting drugs that are more critical.
    • “Most concerning are the shortages of cancer drugs, which until recently hadn’t been much of a problem for at least a decade. There are 15 cancer drugs currently in short supply, according to the Food and Drug Administration, though the White House this week said one of the key shortage chemotherapies, cisplatin, is nearly back to pre-shortage levels.
    • “Civica Rx members choose which drugs it brings to market. So far, the nonprofit contracts for cyclophosphamide, a chemotherapy that helps treat multiple cancers, and there’s a heightened urgency to determine whether to add more cancer drugs to the list.
    • “Given the drug shortage situation for cancer drugs, we have a working group now,” said Allan Coukell, senior vice president of public policy at Civica Rx. “We’re looking at what would a portfolio of those drugs be.”

From the Rx coverage front,

  • Forbes reports
    • “Despite misleading headlines, such as “Sudafed, Benadryl and most decongestants don’t work,” * * * [t]here are branded products that include the names Sudafed and Benadryl that do work as nasal decongestants. These contain the active ingredient pseudoephedrine. But because the dangerous illicit substance methamphetamine can be made in illegal laboratories with pseudoephedrine these products were placed behind the counter years ago. In 2005, Congress passed the Combat Methamphetamine Epidemic Act, which requires that pharmacies and other retail stores maintain purchase logs for products that include pseudoephedrine, and it limits the amount of those products an individual can purchase per day. Pseudoephedrine-based drugs are not affected by the FDA panel’s vote. They will remain available behind the counter.”
  • Per Healthcare Dive,
    • “GoodRx has notched a third partnership with a pharmacy benefit manager to integrate its drug coupons at the point of sale, further expanding GoodRx’s access to the commercially insured PBM market.
    • “For eligible members filling a generic medication starting in 2024, the new program will compare GoodRx’s discount price with their price through insurance and apply the lowest cost. The payment will be automatically applied to consumers’ deductibles.
    • “With MedImpact and existing deals with CVS Caremark and Cigna-owned Express Scripts, GoodRx now reaches more than 60% of insured lives through the partnerships, the company said Wednesday.”
  • The Institute for Clinical and Economic Research published an evidence report for gene therapy to treat Metachromatic Leukodystrophy.
    • “Currently available evidence provides greater certainty of substantial net health benefit in pre-symptomatic MLD; evidence also suggests that individuals with early symptomatic disease benefit from treatment —
      • “Using weighted analyses across all patient subpopulations, arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M – $3.9M —
      • “At the September 29 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money.”

From the U.S. public health front,

  • Healio points out
    • Results from the American Association for Cancer Research’s annual Cancer Progress Report revealed that the age-adjusted overall cancer death rate in the U.S. fell by 33% between 1991 and 2020.
    • The report also detailed FDA approvals related to anticancer therapeutics over the past year, the impact of immunotherapy on cancer care in the 21st century and key challenges needed to overcome obstacles patients with cancer still face moving forward.
  • McKinsey notes” “Orthopedic care is among the largest categories in US healthcare; improvements could have far-reaching positive effects. We analyze care pathways to spot opportunities for better coordination.” Check it out.
  • Per Fierce Healthcare,
    • “Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis.
    • “The analysis was conducted by national drug testing lab Millennium Health, looking at more than 160,000 de-identified urine drug test results from more than 73,000 unique patients collected between mid-April and mid-July 2023. 
    • “Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs. The Biden administration designated fentanyl combined with xylazine an emerging threat in April. “
  • and
    • “Loneliness can have major impacts on seniors’ health, worsening comorbidies and even driving mortality, according to a white paper by the Elevance Health Public Policy Institute.
    • “Loneliness in older adults increases the likelihood of depression and dementia as well as worsening outcomes for individuals with hypertension, heart disease and stroke, according to the white paper.
    • “In a survey, the researchers researchers found that:
      • About 28% of respondents had a mental health condition.
      • About 1 in 4 reported having both depression and another mental health condition.
      • Individuals with a mental health diagnosis were more likely to live alone.
      • Individuals with a mental health diagnosis cited limitations to social activities in the past month because of poor health.
    • “Elevance Health hired research and consulting company Health Management Associates to describe the characteristics of 16,000 Medicare beneficiaries with a mental health diagnosis using the 2018 Medicare Current Beneficiary Survey. Some beneficiaries were covered by traditional fee-for-service Medicare, others by Medicare Advantage (MA).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Medical services provided in outpatient settings are notably pricier when delivered in hospital-owned departments compared with ambulatory surgery centers or physicians’ offices, according to a new analysis from a Blue Cross Blue Shield Association subsidiary.
    • “The report, based on data for 133 million Blues members found from 2017 to 2022, also found prices generally grew more rapidly at hospital outpatient departments than at non-hospital outpatient settings.
    • “Researchers said their data supports site-neutral proposals to make care costs the same regardless of where it’s provided. Momentum is building in Congress around the policies, but they face fierce opposition from hospital groups.”
  • and
    • “Out-of-network ground ambulance rides made up a larger percentage of total claim lines than in-network rides between 2018 to 2022, exposing patients to a higher risk of surprise bills, according to an analysis by Fair Health. 
    • “Out-of-network rides made up almost 64% of all ground ambulance claim lines in 2018, decreasing slightly to over 59% in 2022. 
    • “Advanced life support (ALS) services, which provide a higher level of care than basic life support (BLS), comprised a larger share of ground ambulance claims than basic life support services from 2018 to 2022 — another factor that could drive up costs, the research found. About 51% to 52% of ground ambulance claim lines were associated with ALS during the study period.”

In Social Security and Medicare news,

  • The Detroit Free Press reports,
    • “The odds moved up, based on the latest inflation data, that Social Security benefitscould see a 3.2% cost-of-living adjustment next year. Not sky high but a bit better than average.
    • “To be sure, we’ll need to see one more month of data before the exact inflation adjustment will be known. The next round of Consumer Price Index data for September will be released by the U.S. Bureau of Labor Statistics on Oct. 12.”
  • Per CNET,
    • “Starting in 2024, Medicare Premium costs will be changing — Medicare Part B costs are expected to get more expensive, while Medicare Part D prices are projected to decrease. We’ll tell you how much below. * * *
    • “Due to a new Alzheimer’s treatment coming to the market (Leqembi, from pharmaceutical companies Eisai and Biogen), Medicare beneficiaries are expected to pick up the cost. Therefore, Medicare Part B prices are expected to increase in 2024. The costs are projected to go up from the current $164.90 to $174.80, a nearly $10 increase per month. 
    • “While you may not see a huge difference in the amount you’re paying for Medicare Part D, it still could be slightly lower. The average total monthly Part D premium is projected to decrease from $56.49 in 2023 to $55.50 in 2024, according to the Centers for Medicare & Medicaid Services (CMS). That’s nearly $1 each month.” 

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports, “House Speaker Kevin McCarthy laid out a map for passing legislation to keep the government funded past Oct. 1, but immediately ran into new roadblocks from spending hawks and fresh grumbling that he should be ousted from his post.” The FEHBlog anticipates that Congress will pass a continuing resolution before the end of the month.
  • The Centers for Medicare and Medicaid Services announced,
    • “the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Some people with Medicare who take these drugs may save between $1 and $618 per average dose starting October 1, 2023, depending on their individual coverage.  * * *
    • “CMS has released information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.”
  • Healthcare Dive informs us,
    • “Healthcare legislation being hashed out on the Hill is taking aim at pharmacy benefit managers, but the policies — while potentially worthwhile — are unlikely to have more than modest effects on the cost of prescription drugs in the U.S., experts say. us,
    • “Eliminating all PBM profits would only reduce total drug-related spending by “several percentage points,” since operating margins for the three biggest PBMs averaged roughly 4% of revenues last year, according to a new report from the Brookings Schaeffer Initiative on Health Policy.
    • “Lowering spending further would require “fundamental market changes” like changing drug patent protections or the way drug prices are regulated, the report says — measures sure to face heavy opposition from pharmaceutical companies.”
  • Per Becker’s Hospital Review,
    • “Cisplatin, a drug used for multiple types of cancer that’s been in a severe shortage for months, is close to returning to 100 percent of pre-shortage supply levels, the White House said Sept. 12. * * *
    • “In June and July, the FDA allowed China-based Qilu Pharmaceutical to temporarily import cisplatin. These lots have already been distributed, according to the FDA. The agency also worked with domestic drugmakers to increase their manufacturing capacity. 
    • “These actions brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels and are greatly alleviating the shortages of carboplatin,” according to a post from the White House’s Office of Science and Technology Policy.”
  • The Federal Times writes about the impending premium increases in the Federal Long Term Care Insurance Program.

From the public health and research front,

  • The American Medical Association released a letter supporting the CDC’s “universal recommendation for the 2023-2024 COVID-19, XBB.1.5 containing vaccine.”
  • The National Cancer Institute informs us
    • “Testing for the presence of cancer-causing types of the human papillomavirus (HPV) is now a standard part of screening for cervical cancer, sometimes with simultaneous Pap tests (known as co-testing). But cervical cancer screening is recommended to stop at age 65 in many places and, for a variety of reasons, many older adults stop getting screened for cervical cancer well before that age. 
    • “Results from a population-based study conducted in Denmark, however, suggest that it may be worthwhile for some individuals between ages 65 and 69 to get tested for HPV: those who haven’t had cervical cancer screening for at least 5 years.
    • “In the new study, about 62% of women who were invited to undergo this “catch-up” testing for HPV (intervention group) had a test within the next year. In a comparison group of women not invited for catch-up testing, only about 2% had either a Pap test or an HPV test over the next year.”
  • The Wall Street Journal reports
    • “The first artificial womb to gestate a human baby is fast approaching reality.
    • “Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. * * *
    • “Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials.”
  • Forbes notes, “The Marcus Autism Center in Atlanta has launched its biomarker-based device that has been authorized by the FDA to aid in the diagnosis of autism in children between 16 and 30 months of age.” 

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “After pulling off a biomedical triumph with its COVID-19 vaccine, Moderna on Wednesday put out a roadmap for investors that promises billions of dollars from new medicines.
    • “The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028.”
  • Beckers Payer Issues points out,
    • “Humana, Aetna and Molina are not renewing their contracts with senior companionship company Papa following allegations of abuse against patients or company employees, Bloomberg reported Sept. 11.
    • “In May, Bloomberg Businessweek published a report detailing allegations of abuse against seniors and Papa employees based on 1,200 complaints submitted to the company. The complaints included allegations of sexual abuse and assault, harassment, or unsafe living conditions.
    • “A spokesperson for Papa declined to provide a comment to Bloomberg about specific contracts, but said the company has grown its client base this year and is selling programs for next year.” 

Tuesday Tidbits

David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us
    • “As authorized yesterday by the Food and Drug Administration and recommended by its vaccine advisory committee, the Centers for Disease Control and Prevention today recommended a single dose of the updated Moderna and Pfizer COVID-19 vaccines for Americans aged 12 and older, and one or two doses of the updated vaccines for previously vaccinated children aged six months through 4, at least two months after receipt of their last dose. The agency also recommended three doses of the updated Pfizer vaccine and two doses of the updated Moderna vaccine for unvaccinated children under age 5, as authorized by the FDA and recommended by the committee. CDC anticipates the updated vaccines will be available later this week.
    • “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
  • and
    • The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.
  • FEHBlog observation — The class action lawyers should be revving up the old turbobiller.
  • The U.S. Census Bureau announced
    • “The percentage of working-age adults ages 19 to 64 with health insurance coverage increased from 2021 to 2022, primarily driven by an increase in employment-based coverage. This resulted in uninsured rates dropping from 11.6% to 10.8% according to U.S. Census Bureau data released today [September 12]. 
    • “The Health Insurance Coverage in the United States: 2022 report shows that the share of working-age adults with coverage rose across many race and ethnic groups, regions and employment status.”
  • Beckers Hospital Review informs us
    • CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.   
    • “According to CMS’ price transparency website:
      • Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440. 
      • Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
      • Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
    • The hospitals have 30 days from the issuance date to appeal the fines. 
    • CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.”  
  • ICD Monitor relates
    • “To help improve the collection of the social determinants of health (SDoH) Z codes, the Centers for Medicare & Medicaid Services (CMS) Office of Minority Health last week released a new Z code infographic. 
    • “CMS’s goal is to assist providers with understanding and using SDoH terminology in their documentation that will allow for greater alignment for ICD-10-CM Z code capture.  As discussed, CMS believes that greater Z code capture will enhance quality improvement activities and provide further insights into the existing health inequities that hospitals and their community are facing.” 

From the public health and medical research front,

  • The Wall Street Journal has updated its report on the fall vaccination season.
  • MedTech Dive lets us know,
    • A prospective study published in the journal Lancet Digital Health found that an AI tool paired with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists, the current standard of care.
    • Researchers at the Capio Sankt Göran Hospital in Stockholm, Sweden, and the Karolinska Institute said the results suggest that AI “has potential for controlled implementation, which would include risk management and real-world follow-up of performance.” 
    • The study used the Insight MMG system for breast cancer detection, made by Seoul, South Korea-based Lunit. The company helped fund the research, in addition to grants from the Swedish Research Council, the Swedish Cancer Society, and Region Stockholm.
  • The American Hospital Association News reports,
    • “The U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2% to 19,928, the Centers for Disease Control and Prevention reported Sept. 12. The mortality rate increased for infants of Asian women and declined for infants of Dominican women. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight. Infant mortality rates by state ranged from a low of 2.77 in North Dakota to a high of 9.39 in Mississippi. The U.S. infant mortality rate has generally trended downward since 1995 and has declined 21% since 2005, the most recent high (6.86).”
  • STAT News is now offering a new generation weight loss drug tracker.
    • “STAT has created a new database to track the significant obesity drugs that are on the market and in development. The tracker, which will be updated with developments each quarter, gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.
    • “A related article details the strategies and challenges of some of these companies.”
    • Roughly seventy drugs are on the tracker currently.

From the U.S. healthcare business front,

  • Fierce Healthcare tells us, “Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.”
  • Per Healthcare Dive,
    • “Walgreens is partnering with startup Pearl Health to help primary care physicians manage value-based care, in a bid to expand its reach with community-based providers.
    • “The partnership announced Tuesday [September 12] marries Pearl’s provider enablement technology with Walgreens’ care delivery assets and pharmacy services in an attempt to make it easier for clinical teams to provide the personalized treatment necessary in value-based arrangements, according to the companies.
    • “Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
  • Per Employee Benefits News,
    • “Saving for retirement is a life-long challenge, and one that seems to be harder for women. While they live on average five years longer than men, they’re saving less.
    • “Bank of America analyzed 565,000 health savings accounts (HSAs), looking at utilization trends across genders and generations. Women’s HSA balances are 15% lower than men’s, with women more likely to spend their HSA savings before retirement and contribute less to their accounts. Overall, men’s average net HSA savings was $128 higher in 2022, and over the years that gap begins to add up.” * * *
    • “Lisa Margeson, managing director of retirement research and insights at Bank of America,  advises employers to at the very least educate their employees on the power of HSAs and how they can use them as retirement savings vehicles. Employer HSA contributions, caregiving benefits and flexibility will also help ensure women can maintain successful careers and save for their future. 
    • “As for women, Margeson encourages them to start their HSAs early, try to put at least a little aside each month and eventually invest that money according to their bank’s capabilities. For those who are uncomfortable with a high-deductible health plan, Margeson points to emergency savings accounts or an interest-bearing savings account as a companion to their retirement plans.”
  • The Society for Human Resource Management offers a breakdown of compensation expenses over the second quarter of this year.
    • “According to the latest Employer Costs for Employee Compensation report, released September 12 by the U.S. Bureau of Labor Statistics (BLS), employers spent just 0.59 percent more on wages and benefits in June 2023 compared to March 2023.
    • “Total employer compensation costs for private-industry workers averaged $41.03 per hour worked. Wages and salaries averaged $28.97 per hour worked, accounting for 70.6 percent of employer costs, while benefits costs averaged $12.06 per hour worked, accounting for the remaining 29.4 percent, according to the report.”

Friday Factoids

David Ermer–CDC, CMS, HSA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The American Hospital Association informs us
    • “The 988 Suicide & Crisis Lifeline now offers American Sign Language services for people who are deaf and hard of hearing, the Department of Health and Human Services announced.
    • “This new service is one more critical step towards making mental health support more accessible and inclusive for all,” said Miriam Delphin-Rittmon, HHS assistant secretary for mental health and substance use.”
  • and
    • “A new Centers for Medicare & Medicaid Services fact sheet reviews how the agency selected the first 10 Part D drugs to include in the Medicare Drug Price Negotiation Program, its process for negotiating with the companies that make the drugs, opportunities for public input and key dates for implementation. CMS last week announced the first 10 drugs for the program and plans to publish the negotiated prices by next September, which would take effect in 2026.”
  • The Department of Health and Human Services announced
    • “new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants.
    • “The HHS is committed to lowering drug costs for all Americans. As part of that commitment, HHS and Regeneron announced an extension of their long-standing partnership to develop life-saving monoclonal antibodies. That modification to Regeneron’s contract with the Administration for Strategic Preparedness and Response’s (ASPR’s) Biomedical Advanced Research and Development Authority is valued at $326M and supports the advanced development of a next-generation monoclonal antibody for COVID-19 prevention under HHS’s Project NextGen.
    • “This agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally. Inclusion of this clause is the result of HHS’s and Regeneron’s shared interest in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans.”

From the public health front,

  • The American Hospital Association tells us
    • “This season’s flu vaccines for the Southern Hemisphere have reduced the risk of being hospitalized for flu by 52%, based on mid-season data from five countries, suggesting the U.S. vaccines could provide similar protection if similar viruses continue to predominate, the Centers for Disease Control and Prevention reports. Both hemispheres used similar flu vaccine formations. The CDC recommends all Americans aged 6 months and older get the seasonal flu vaccine in September or October.”
  • Per Health Day,
    • “The mpox vaccine appears to show effectiveness against the virus, new research shows
    • “Among 37 gay and bisexual men who were either reinfected or had received their mpox vaccine, the disease was less severe
    • “The findings show that the vaccine is a valuable addition to treatments used for mpox infection.”
  • and
    • “Standard Pap tests may miss a deadly type of cervical cancer 
    • “A new screening tool could pick up more of those cancers as well as lesions that may progress into cancer, its developers say
    • “The findings must now be confirmed by clinical trials”
  • More details are available in the Health Day articles.
  • A Wall Street Journal reporter explains what he learned from trying to live a perfect life for a day based on expert advice.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health shuffled responsibilities for its leadership bench on Thursday in a bid to better align business segments, as the retail health giant undergoes corporate restructuring following flagging earnings.
    • “CVS named CFO Shawn Guertin president of its health services segment, and said former Humana CFO Brian Kane will join this week as president of Aetna health benefits arm. CVS first announced Kane would be joining CVS in April.
    • “CVS’ care delivery businesses Oak Street Health and Signify Health will continue to operate under health services umbrella. Their respective heads, Mike Pykosz and Kyle Armbrester, will now report directly to Guertin.”
  • Beckers Payer Issues notes,
    • “AHIP has named its general counsel, Julie Simon Miller, to serve as interim CEO, effective Oct. 2.
    • “AHIP President and CEO Matt Eyles is stepping down from his role at the end of September, and the trade association is currently searching for a permanent chief executive, according to a Sept. 7 news release.
    • “Ms. Miller has served as general counsel since 2015 and has been with the association for more than 18 years.”
  • The Employee Benefit Research Institute points out,
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 medications and services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. A 2021 Employee Benefit Research Institute (EBRI) survey of employers collected information on their response to the 2019 guidance and found that many employers added pre-deductible coverage as a result of the IRS notice. A recent EBRI report based on claims data from about 2 million HSA-eligible health plan enrollees confirmed the findings from the 2021 EBRI survey — fewer enrollees in HSA-eligible health plans have deductibles for services impacted by the IRS notice, and cost sharing has shifted from deductibles to copayments and coinsurance.”
  • Per Fierce Healthcare,
    • “Prior authorization will become less of a hassle for physicians in Blue Cross Blue Shield of Michigan’s network, BCBSM officials hope, as they roll out an effort to relax about 20% of prior authorization requirements.
    • “This is part of Blue Cross’ ongoing effort to improve healthcare quality, experience, access and affordability for members, while also reducing administrative tasks for clinicians,” BCBSM said in a press release.”

From the Rx coverage and research front,

  • BioPharma Dive reports,
    • “Seagen is committing $60 million to develop a new type of cancer drug, striking a multi-year alliance with biotechnology company Nurix that aims to combine their respective technologies.
    • “Per terms of the deal announced by Nurix Thursday, Seagen could pay as much as $3.4 billion more if certain research, development, regulatory and commercial milestones are met. Nurix retains an option to co-market and share profits on two products that emerge from the partnership.
    • “The companies plan to pair Seagen’s antibody expertise with Nurix’s protein degradation technology to create “degrader-antibody conjugates,” akin in some ways to Seagen’s approved antibody-drug conjugates. The collaboration comes as Pfizer works to close its $43 billion acquisition of Seagen.”
  • and
    • “Verge Genomics, a biotechnology company using artificial intelligence to develop therapies for diseases of the nervous system, announced on Friday a four-year partnership with AstraZeneca’s rare disease unit Alexion to identify new drug targets.
    • “As part of the agreement, Verge will receive up to $42 million in upfront, equity and near-term payments. The company also could receive as much as $840 million in milestone payments over the deal, along with royalties on any resulting products.
    • “The partnership seeks to find and validate new drug targets for uncommon neurodegenerative and neuromuscular diseases. The companies plan to do this by using Verge’s technology, which uses both AI and human tissue data to predict what drug targets are most likely to succeed in clinical testing.”

Thursday Miscellany

David Ermer–CMS, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC,

  • The Washington Post reports
    • “The White House on Thursday urged Congress to adopt a short-term measure to fund the federal government, a move meant to buy time for lawmakers to craft a broader spending deal and avert a shutdown at the end of September.
    • “The Biden administration coupled its call to action with a new request that Congress address funding for a series of cash-starved programs — including, for example, an additional $1.4 billion to prevent a potential disruption in nutritional aid for low-income families.”
  • HHS Secretary Xavier Berrara reflected on the Administration’s efforts to end the opioid public health emergency on this International Overdose Awareness Day.
  • In related news, the New York Times informs us
    • “Narcan, the first opioid overdose reversal medication approved for over-the-counter purchase, is being shipped to drugstore and grocery chains nationwide, its manufacturer said Wednesday. Big-box outlets like Walgreens, CVS, Walmart and Rite Aid said they expected Narcan to be available online and on many store shelves early next week.
    • “Public health experts have long called for greater accessibility to the drug, which they describe as a critical weapon against rising overdose rates. There were more than 100,000 opioid overdose fatalities in each of the last two years in the United States.
    • “Narcan is already a staple for emergency personnel and street outreach teams. Now scientists and health officials are hoping Narcan will eventually become commonplace in public libraries, subways, dorms, corner delis and street vending machines.
    • “They also predict it may become a fixture in medicine cabinets, as more people realize that illicit party drugs like cocaine and counterfeit Xanax pills may be tainted with deadly fentanyl, an opioid.”
  • Govexec relates
    • “President Biden on Thursday formalized his plan to provide civilian federal employees with an average 5.2% pay increase, their largest in four decades, in a letter to congressional leaders.
    • “In March, Biden first announced his pay raise plan as part of his fiscal 2024 budget proposal, recommending the largest pay increase for civilian federal workers since the Carter administration. Thursday’s announcement confirms that, if implemented, federal employees will see an across-the-board increase in basic pay of 4.7% and an average 0.5% boost to locality pay.
    • “In his letter, Biden said the pay raise is critical to his administration’s goal of ensuring that the federal government is a model employer and able to attract qualified candidates to join the workforce.”
  • The U.S. Office of Personnel Management announced issuing
    • the final regulations to implement the Fair Chance to Compete for Jobs Act of 2019 (Fair Chance Act), which prohibits federal agencies and federal contractors from requesting an applicant’s criminal history information before the agency makes a conditional offer of employment to the applicant. The final regulations also provide applicants with a complaint process and hold accountable federal employees who are in violation of the Fair Chance Act. 
    • “If you have the qualifications, skills, and willingness to serve the American public, you deserve a fair chance to compete for employment within the federal government,” said Kiran Ahuja, OPM Director. “America is a nation of second chances, and every person deserves to be treated with dignity and respect.” 

From the Medicare front,

  • MedPage Today reports on CMS efforts to recruit specialty practices in Medicare value-based purchasing programs.
  • Milliman issued a white paper titled “Part D redesign under the Inflation Reduction Act / Potential financial ramifications for Part D plans and pharmaceutical manufacturers.” Check it out.
  • CMS recently announced
    • “a new voluntary nationwide model – the Guiding an Improved Dementia Experience (GUIDE) Model – a model test that aims to support people living with dementia and their unpaid caregivers. CMS is accepting letters of interest for the GUIDE Model through September 15, 2023, and will release a GUIDE Request for Applications (RFA) for the model in Fall 2023. The model will launch on July 1, 2024, and run for eight years. * * *
    • “Participants in the GUIDE Model will establish dementia care programs (DCPs) that provide ongoing, longitudinal care and support to people living with dementia through an interdisciplinary team. GUIDE participants will be Medicare Part B enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model.”

From the public health and medical research fronts

  • We have four articles from STAT News
    • Miscarriage treatment news. “A [Woodbury,] Minnesota clinic tries to rewrite medicine’s approach to miscarriage.” Bravo.
    • CAR-T Therapy News — “Saar Gill and Carl June, cell therapy researchers at the University of Pennsylvania, wanted to make a single treatment that could tackle virtually all blood cancers. It was an audacious goal. * * *
    • “On Thursday, though, Gill, June and a graduate student, Nils Wellhausen, published a solution in Science Translational Medicine. It’s a complicated dance involving a new form of genome editing and multiple cellular infusions, and still years away from clinical trials. But outside experts say that if academics or companies can figure out manufacturing and logistics, it could open new avenues to tackling cancers that have so far remained out of reach.
    • “It’s very clever and really a tour de force,” said Marcela Maus, director of the cellular immunotherapy program at Mass General Hospital.”
    • Depression treatment news — “A single dose of psilocybin may have enduring benefits for people with major depressive disorder, according to a randomized clinical trial published Thursday in the Journal of the American Medical Association.”
    • AD Treatment News — Drug firms are studying whether drugs like Leqembi can halt Alzheimer’s Disease before symptoms appears.
  • From the U.S. healthcare business front,
    • Per Fierce Healthcare,
      • “GoodRx has launched a new feature to allow healthcare professionals to see the cost of a patient’s prescription with their insurance.
      • “The real-time benefit check (RTBC) feature was developed in collaboration with AssistRx, a specialty therapy initiation and patient solutions provider. The RTBC surfaces a patient’s coverage and benefits at the point of care with the goal of increasing price transparency and access to drugs. It also includes whether a prior authorization is required.
      • “AssistRx built its advanced access and patient support solutions to be interoperable, Edward Hensley, the company’s co-founder and chief commercial officer, said in a press release.”

Midweek update

David Ermer–FDA, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Florida to address the health impacts of Hurricane Idalia and the Administration for Strategic Preparedness and Response (ASPR) deployed approximately 68 emergency response personnel to the state. At President Biden’s direction, HHS is aiding impacted communities through the Administration’s whole-of-government response effort.”
  • The Society for Human Resource Management informs us,
    • “The Department of Labor (DOL) has proposed an increase to the Fair Labor Standards Act’s (FLSA’s) annual salary-level threshold to $55,068 from $35,568 for white-collar exemptions to overtime requirements. The department also is proposing automatic increases every three years to the overtime threshold. * * * *
    • “To be exempt from overtime under the FLSA’s “white-collar” executive, administrative and professional exemptions, employees must be paid a salary of at least the threshold amount and meet certain duties tests. If they are paid less or do not meet the tests, they must be paid 1 and a half times their regular hourly rate for hours worked in excess of 40 in a workweek. * * *
    • “Under the new rule, approximately 300,000 more manufacturing workers would be entitled to overtime pay, the Labor Department reports. A similar number of retail workers would be eligible, along with 180,000 hospitality and leisure workers, and 600,000 in the health care and social services sector.” 
  • MedCity News relates,
    • “A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and positioning the therapy to achieve its blockbuster expectations.
    • “The drug, Reblozyl, treats myelodysplastic syndromes (MDS), a group of cancers in which the immature blood cells in bone marrow do not mature to become healthy blood cells. In 2020, the FDA approved Reblozyl as a second-line treatment for the anemia resulting from MDS. The FDA decision announced late Monday makes it a first-line therapy.”
  • The National Institutes of Health announced,
    • “In a study of 152 deceased athletes less than 30 years old who were exposed to repeated head injury through contact sports, brain examination demonstrated that 63 (41%) had chronic traumatic encephalopathy (CTE), a degenerative brain disorder associated with exposure to head trauma. Neuropsychological symptoms were severe in both those with and without evidence of CTE. Suicide was the most common cause of death in both groups, followed by unintentional overdose.
    • “Among the brain donors found to have CTE, 71% had played contact sports at a non-professional level (youth, high school, or college competition). Common sports included American football, ice hockey, soccer, rugby, and wrestling. The study, published in JAMA Neurology, confirms that CTE can occur even in young athletes exposed to repetitive head impacts. The research was supported in part by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.” 

From the public health, medical research and Rx coverage fronts,

  • STAT News reports,
    • “The first Alzheimer’s therapy to clearly slow cognitive decline, approved in the United States last month, lifted the hope of patients and their families. But creating access to the program is a painfully slow process, even in Massachusetts, where large hospital systems have been preparing for months to administer the much-anticipated medicine.
    • “Thousands of patients are stuck on waiting lists across the state and nationally as hospitals struggle to ramp up infusion centers and monitoring processes for the drug, called Leqembi, while neurologists grapple with workforce and capacity constraints. * * *
    • “Hospitals say the backlog is temporary, reflecting the challenge of building from scratch a treatment infrastructure for new Alzheimer’s drugs. Leqembi, developed by Biogen and its Japanese partner, Eisai, was the first such treatment to be green-lighted by the Food and Drug Administration. The agency will evaluate a second therapy, Eli Lilly’s donanemab, later this year.”
  • and
    • “KRAS, one of the most common genetic mutations in cancer, has been one of the most tantalizing oncogenic targets for drug developers since its discovery four decades ago. An altered KRAS gene can drive cells to divide uncontrollably, propelling them down the path towards malignancy. But for most of the last four decades, any attempt to target KRAS failed, leading many researchers to doom the protein as “undruggable.”
    • “In the last few years, that attitude has sharply turned around. In 2013, Kevan Shokat, a biologist at the University of California, San Francisco, discovered a key chemical vulnerability in a specific subset of mutant oncogenic KRAS that made it possible to design small molecules that would bind to the protein. This discovery catalyzed a frenzy of drug development around KRAS inhibitors, which eventually led to the first approved KRAS drugs in the last couple of years. Those successes are now driving a new wave of early-stage innovation around the target.
    • “It broke the code for us, for KRAS,” said Ravi Salgia, chair of medical oncology and therapeutics research at the City of Hope. “That gives us more hope to say we’ve spent more than 30 years studying it. Now, great breakthroughs have occurred. Let’s keep going forward.”
    • “That includes work around new small molecules for other subsets of mutant KRAS as well as immunotherapy approaches for targeting the oncogene. These therapies could potentially treat a wide range of different KRAS-mutant cancers including lung, pancreas, and colorectal cancers.”
  • CNN tells us,
    • “A group of novel synthetic opioids emerging in illicit drugs in the United States may be more powerful than fentanyl, 1,000 times more potent than morphine, and may even require more doses of the medication naloxone to reverse an overdose, a new study suggests.
    • “Nitazenes are a synthetic opioid, like fentanyl, although the two drugs are not structurally related. In the small study published Tuesday in the journal JAMA Network Open most of the patients who overdosed on nitazenes received two or more doses of the opioid overdose reversal drug naloxone, whereas most patients who overdosed on fentanyl received only a single dose of naloxone.
    • “Clinicians should be aware of these opioids in the drug supply so they are adequately prepared to care for these patients and anticipate needing to use multiple doses of naloxone,” the researchers, from the Icahn School of Medicine at Mount Sinai in New York, Lehigh Valley Health Network based in Pennsylvania, and other US institutions, wrote in the study. “In addition, to date there has been a lack of bystander education on repeat naloxone dosing.”

From the U.S. healthcare business front,

  • Per Healthcare Dive, and the FEHBlog agrees,
    • “Ensuring workers can find and access high-quality providers is key to tamping down healthcare costs and improving outcomes in the employer-sponsored insurer market, according to a study by Morgan Health and Embold Health published in NEJM Catalyst. 
    • “Employers can now access more data on the quality of care provided by clinicians, so they should take a larger role in health plan network design and steer workers toward higher-performing providers, according to the report. 
    • “Clinician quality can drive poor outcomes, missed treatments and unnecessary care, the report said. For example, among the top 10% of about 800 cardiologists in Ohio by quality rank, an average of 73% of patients with coronary artery disease were taking cholesterol-lowering statins regularly, compared with only 39% for the bottom 10% of clinicians.” 
  • The Wall Street Journal reports
    • “In a male-dominated industry, female surgeons spend more time in the operating room, and their patients endure fewer postoperative complications.
    • “That’s the conclusion of two research studies published Wednesday in JAMA Surgery. Researchers found better outcomes for patients treated by female surgeons in the sweeping reviews of millions of procedures in Canada and Sweden. 
    • “In the first study, 17 researchers in the U.S. and Canada followed the outcomes for 1.2 million patients in Canada undergoing common surgeries between 2007 and 2020.
    • “The study authors found that at both 90 days and one year following surgery, patients treated by female surgeons were less likely to experience adverse postoperative issues, including death. The outcome differences were modest, but consistent.”
  • Fierce Healthcare relates,
    • “Earlier this year, Anthem Blue Cross and Blue Shield unveiled a new virtual-first plan that harnesses artificial intelligence to streamline health services for members, the insurer announced.
    • “Now, it’s making that plan available in several additional states beginning Jan. 1. Large group fully insured or self-funding employer clients in Connecticut and Virginia can select Anthem Link Virtual First plans, which harness the power of the insurer’s Sydney app to connect members with benefits details, cost transparency information and more around the clock.
    • “Stephanie DuBois, a spokesperson for Anthem Blue Cross and Blue Shield in Connecticut, told Fierce Healthcare in an email that the plans first became available to large group self-insured employers in California, Missouri and New York as well as large group self-funded and fully insured employers in Georgia starting in July.
    • “Members can access Anthem Link Virtual First plans through Sydney Health, which is a digital member engagement platform that includes access to benefits, tools, resources and provider care 24/7,” DuBois said. “Sydney Health also offers an AI-driven symptom checker that intuitively uses the information members provide to narrow down millions of medical data points and assess specific symptoms before seeing a doctor.”

Tuesday’s Tidbits

David Ermer–Electronic health records, Medicare, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “The U.S. government named 10 drugs that will be subject to the first ever price negotiations by Medicare, taking aim at some of the most widely used and costliest medicines in America.
    • “At stake is arguably the government’s strongest effort to date to tackle high drug costs—if drugmakers can’t persuade courts to scuttle the negotiating powers that Medicare was granted last year.
    • “On the list of targeted medicines announced by the Biden administration Tuesday are treatments for cancer, diabetes and heart disease that can cost tens of thousands of dollars a year or more, including blood thinner Eliquis and diabetes treatment Jardiance.”
  • STAT News adds, “The new prices will be announced on Sept. 1, 2024, and will go into effect on Jan. 1, 2026.”   
  • Bloomberg informs us,
    • “For millions of American patients and parents struggling to fill prescriptions for ADHD medications that are in short supply, help is on the way. 
    • “US regulators approved a generic form of Takeda Pharmaceuticals Co.’s Vyvanse, which some patients may be able to take in place of generic Adderall, the drug of choice for many with ADHD. That drug, made by a number of manufacturers, has been in shortage for a year, forcing patients and their families to scour pharmacies for supplies or go without. 
    • “The approval will also likely bring financial relief to the more-than one million Americans who take branded Vyvanse to treat ADHD or binge-eating disorder. The cost of the drug has been steadily climbing since it was introduced in 2007, and today the list price of a 30-day supply is $369.
    • “Generic Vyvanse can be manufactured and sold by 14 companies, according to a Food and Drug Administration database updated Friday [August 25].
  • HC Innovation Group points out,
    • “Leaders at the Sequoia Project, a non-profit, 501c3, public-private collaborative chartered to advanced implementation of secure, interoperable nationwide health information exchange (HIE), announced on Aug. 28 that the Office of the National Coordinator for Health IT (ONC) has confirmed that the Sequoia Project will continue forward as the Recognized Coordinating Entity (RCE) for TEFCA—the Trusted Exchange Framework and Common Agreement. * * *
    • “The Sequoia Project and our RCE team are extremely proud of TEFCA’s progress to date, and we look forward to bringing its promise and benefits to reality soon. We couldn’t have gotten this far without close collaboration with ONC and the candidate QHINs (Qualified Health Information Networks),” said Mariann Yeager, CEO of The Sequoia Project, in a statement contained in the press release. “We’ve engaged stakeholders throughout the development process to engender public trust and instill a sense of ownership for future QHINs. We look to the coming months and years where this multi-year vision becomes a reality.”
  • Everyone in healthcare looks forward to this vision of an EHR backbone becoming a reality.
  • The HHS Office of Inspector General posted a strategic plan for overseeing managed care in the Medicare and Medicaid programs.
  • The U.S. Preventive Services Task Force proposed an inconclusive recommendation for requiring primary care providers “to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment.” The relevant population is “Children and adolescents younger than age 18 years without signs and symptoms of maltreatment.” Public comment is open through September 25, 2023.

From the public health front, McKinsey & Company offers an enlightening exploration of brain health.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark Health reported $13.6 billion in revenue for the first half of 2023 as well as $389 million in net income.
    • “The not-for-profit Blues insurer attributed the performance to positive results at most of its segments, namely its core health plan as well as United Concordia Dental. In addition, volumes at Allegheny Health Network were were up year over year, further driving greater revenue.
    • “The health system reported an 8% increase inpatient discharges and observations compared to the first half of 2022 and a 6% increase in outpatient registrations. Physician visits were also up 6%, and emergency room visits were up 8% across the network.
    • “Earnings before interest, taxes, depreciation and amortization at Allegheny Health Network were $68 million in the first six months of 2023, and the network reported $2.3 billion in operating revenue.”
  • Reuters says,
    • “Pfizer (PFE.N) said on Monday it expects to restart production at its North Carolina plant by the beginning of the fourth quarter of 2023 as it seeks to repair tornado damage to one of the world’s largest sterile injectable drug facilities.
    • “The facility was struck by a tornado on July 19, and Pfizer had earlier said some drugs, including painkiller fentanyl, could see a supply disruption. Pfizer has since placed limits on how much supply of those drugs its customers can buy.”